Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00748813
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : December 1, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:
Annual trial for registration influenza vaccine with the strain composition for season 2008/2009

Condition or disease Intervention/treatment Phase
Seasonal Influenza Biological: Influenza Vaccine, Formulation 2008-2009 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Sub
Study Start Date : June 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
1 Biological: Influenza Vaccine, Formulation 2008-2009
1 dose of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009

Primary Outcome Measures :
  1. Evaluation of antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) test on Day 0 and on Day 21 [ Time Frame: 21 days (-1/+5) ]

Secondary Outcome Measures :
  1. Evaluation of safety [ Time Frame: 21 days (-1/+5) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects eligible for enrollment into this study are male and female adults who are:

    1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
    2. able to comply with all study requirements
    3. in good health as determined by:
  • medical history
  • physical examination
  • clinical judgment of the investigator

Exclusion Criteria:

  • They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:

    1. Cancer, except for localized skin cancer;
    2. Advanced congestive heart failure;
    3. Chronic obstructive pulmonary disease (COPD);
    4. Autoimmune disease (including rheumatoid arthritis);
    5. Acute or progressive hepatic disease;
    6. Acute or progressive renal disease;
    7. Severe neurological or psychiatric disorder;
    8. Severe asthma.
  • They have history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
  • They have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
  • receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;
  • receipt of immunostimulants;
  • receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
  • suspected or known HIV infection or HIV-related disease;
  • They have a known or suspected history of drug or alcohol abuse;
  • They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
  • Women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days);
  • Within the past 12 months, they have:
  • received more than one injection of influenza vaccine
  • Within the past 6 months, they have:
  • had laboratory confirmed influenza disease;
  • received influenza vaccine;
  • Within the past 4 weeks they have received:
  • another vaccine;
  • any investigational agent;
  • They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 1 - They have experienced an acute exacerbation of a COPD within the past 14 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00748813

Site 1
Chieti, Italy, 66100
Site 2
Lanciano, Italy, 66034
Site 3
Pianiga, Italy, 30034
Sponsors and Collaborators
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines

Additional Information:
Responsible Party: Novartis Vaccines Identifier: NCT00748813     History of Changes
Other Study ID Numbers: V71P7S
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: December 2011

Keywords provided by Novartis ( Novartis Vaccines ):
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs